A Rapid, Stability Indicating RP-UPLC Method for Determination of Paliperidone Palmitate in a Depot Injectable Formulation.
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Date
2013-07
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Abstract
A rapid, stability-indicating reversed phase ultra-performance liquid chromatographic (RP-UPLC) method was
developed for the determination of paliperidone palmitate (PP), in depot injectable dosage form. The
chromatographic separation was achieved on an Acquity BEH C18 (50 mm × 2.1 mm, 1.7 μm) column, with a
mobile phase consisting of ammonium acetate buffer, and acetonitrile at a ratio of 10:90 (v/v) and a flow rate of
0.6 mL/min. The eluted compound was monitored at a wavelength of 238 nm using a UV detector. The method
described herein separated paliperidone palmitate from all other formulation components and two major known
degradation products (N-Oxide and paliperidone) within a run time of 2.5 min. The method also generated linear
results over a PP concentration range of 156 to 468 μg/mL. The stability indicating capability of the method was
established by performing forced degradation experiments. The RP-UPLC method that was developed was
validated according to the International Conference on Harmonization (ICH) guidelines. This method was
successfully applied in the quantitative determination of PP in a stability study of paliperidone palmitate depot
injection. The procedure described herein is simple, selective, and reliable for routine quality control analysis as
well as stability testing.
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Keywords
Depot, Chromatography, Extended-release suspension, Assay, Method validation, Paliperidone palmitate injection, Schizophrenia
Citation
Trivedi Rakshit Kanubhai, Jain Prashant, Patel Mukesh C, Chatrabhuji Parimal M, Trivedi Dipika R. A Rapid, Stability Indicating RP-UPLC Method for Determination of Paliperidone Palmitate in a Depot Injectable Formulation. Journal of Applied Pharmaceutical Science. 2013 July; 3(7): 87-92.